Identity
- Trade Name
- MEDENTiKA FDA UDI
- Generic Name
- Dental implant suprastructure, permanent, preformed FDA UDI
- Device Name
- Multi-unit abutment FDA UDI
- Model / Reference
- E 8400 FDA UDI
- Description
- Multi-unit abutment FDA UDI
Identifiers
- Catalog Number
- E 8400 FDA UDI
- Primary DI / UDI-DI
- 04251574850294 FDA UDI
- 510(k) Number
- K223113 FDA UDI
- FDA Product Code
- NHA FDA UDI
- GMDN Term
- Dental implant suprastructure, permanent, preformed FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3630 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Conditional FDA UDI
Category: Dental implant suprastructure, permanent, preformed
MEDENTiKA by Medentika GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental implant suprastructure, permanent, preformed.
- SPARE CAST. SLEEVE FOR — SWEDEN & MARTINA INC · Class II
- HS/HG Prosthetic System — OSSTEM IMPLANT Co., Ltd. · Class II
- DESS dental smart solutions — TERRATS MEDICAL SL. · Class II
- Diamodent — Diamodent · Class II
- Cemented Abutment — POINTIMPLANT Co., Ltd. · Class II
- GS System — OSSTEM IMPLANT Co., Ltd. · Class II
- Temporary Abutment — Cybermed Inc. · Class II
- EZ Post — Megagen Implant Co. Ltd · Class II
Cleared under the same submission
K223113 also covers:
- MEDENTiKA — Medentika GmbH
- MEDENTiKA — Medentika GmbH
- MEDENTiKA — Medentika GmbH
- MEDENTiKA — Medentika GmbH
- MEDENTiKA — Medentika GmbH
- MEDENTiKA — Medentika GmbH
- MEDENTiKA — Medentika GmbH
- MEDENTiKA — Medentika GmbH
- MEDENTiKA — Medentika GmbH
- MEDENTiKA — Medentika GmbH
- MEDENTiKA — Medentika GmbH
- MEDENTiKA — Medentika GmbH
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Medentika GmbH
Sources (1)
- FDA UDI 76185145-cde8-4d8d-b0cb-4500d30df294 36 fields · synced Jun 8, 2026